Study on Total Therapy for Infants with Acute Lymphoblastic Leukemia (ALL) I

Program Overview

The purpose of this study is to explore the effects of adding two drugs, bortezomib and vorinostat, to the usual chemotherapy treatment for infants with acute lymphoblastic leukemia (ALL). These drugs are already approved for treating other cancers in adults but not for children with leukemia. The study will look at how well infants tolerate these drugs and whether they help improve survival rates. Researchers will also measure the amount of leukemia cells left after treatment and compare it to previous studies.

Description

The treatment plan includes four main phases: Remission Induction, Consolidation, Reinduction, and Maintenance. High-risk patients may have an additional phase before a stem cell transplant.

• Remission Induction: This phase uses chemotherapy to try to put the leukemia into remission. Drugs include methotrexate, hydrocortisone, Ara-C, dexamethasone, vorinostat, bortezomib, PEG-asparaginase, mitoxantrone, cyclophosphamide, cytarabine, and 6-mercaptopurine.

• Consolidation Phase: After recovery from the first phase, this phase aims to kill any remaining leukemia cells using methotrexate and 6-mercaptopurine.

• Re-Induction: This phase seeks to further improve the response to treatment and includes drugs like mitoxantrone, peg-asparaginase, dexamethasone, bortezomib, and vorinostat. Patients who respond well may proceed to a stem cell transplant.

• Re-Intensification: For patients who still have leukemia cells after previous phases, additional treatments like Chimeric Antigen Receptor T-Cell therapy (if available) or further chemotherapy may be given before a stem cell transplant.

• Maintenance Phase: Patients with no detectable leukemia cells after consolidation will receive maintenance therapy to prevent the cancer from returning. This involves cycles of methotrexate, dexamethasone, vincristine, and 6-mercaptopurine, repeated up to 20 times if tolerated.

Eligibility Criteria

Locations